Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) (FLEX)
13 giugno 2014 aggiornato da: Merck KGaA, Darmstadt, Germany
Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy.
Overall survival will be taken as primary measure of efficacy.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1861
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina
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Cordoba, Argentina
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Adelaide, Australia
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Melbourne, Australia
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Randwick, Australia
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Sydney, Australia
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Wodonga, Australia
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Wien, Austria
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Bruxelles, Belgio
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Charleroi, Belgio
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Liège, Belgio
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Porto Alegre, Brasile
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Sao Paulo, Brasile
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Pleven, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Veliko Tarnovo, Bulgaria
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Antofagasta, Chile
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Santiago de Chile, Chile
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Seoul, Corea, Repubblica di
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Moscow, Federazione Russa
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St. Petersburg, Federazione Russa
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Brest, Francia
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Caen, Francia
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Grenoble, Francia
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Marseille, Francia
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Paris, Francia
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Poitiers, Francia
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Rennes, Francia
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Rouen, Francia
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Strasbourg, Francia
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Augsburg, Germania
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Berlin, Germania
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Essen, Germania
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Freiburg, Germania
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Gauting, Germania
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Großhansdorf, Germania
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Göttingen, Germania
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Halle-Dölau, Germania
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Hamburg, Germania
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Heidelberg, Germania
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Köln, Germania
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Löwenstein, Germania
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Magdeburg, Germania
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Mainz, Germania
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München, Germania
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Stralsund, Germania
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Wuppertal, Germania
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Honh Kong, Hong Kong
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Dublin, Irlanda
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Bologna, Italia
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Carpi, Italia
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Milano, Italia
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Rome, Italia
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Rozzano-Milano, Italia
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Treviglio, Italia
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Mexico-City, Messico
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Monterrey, Messico
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Amsterdam, Olanda
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Nieuwegeln, Olanda
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Zwolle, Olanda
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Bydgoszcz, Polonia
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Olsztyn, Polonia
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Otwock, Polonia
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Posnan, Polonia
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Warszawa, Polonia
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Wroclaw, Polonia
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Aberdeen, Regno Unito
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Bristol, Regno Unito
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Edinburgh, Regno Unito
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Leicester, Regno Unito
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London, Regno Unito
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Newcastle upon Tyne, Regno Unito
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Poole, Regno Unito
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Sutton, Regno Unito
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Wolverhampton, Regno Unito
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Brno, Repubblica Ceca
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Ostrava, Repubblica Ceca
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Pilsen, Repubblica Ceca
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Praha, Repubblica Ceca
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Singapore, Singapore
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Banska Bystrica, Slovacchia
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Bratislava, Slovacchia
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Nitra-Zobor, Slovacchia
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Poprad, Slovacchia
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Barakaldo (Bilbao), Spagna
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Barcelona, Spagna
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Elche Alicante, Spagna
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Granollers, Spagna
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Madrid, Spagna
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Pamplona, Spagna
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Pontevedra, Spagna
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San Sebastian, Spagna
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Santander, Spagna
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Terrassa, Spagna
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Valencia, Spagna
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Stockholm, Svezia
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Uppsala, Svezia
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Bern, Svizzera
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Thun, Svizzera
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Zürich, Svizzera
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Ankara, Tacchino
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Taipei, Taiwan
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Tao Yuan County
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Taipei, Tao Yuan County, Taiwan
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Dnipropetrovsk, Ucraina
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Kharkiv, Ucraina
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Kyiv, Ucraina
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Lviv, Ucraina
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Poltava, Ucraina
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Sumy, Ucraina
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Ternopol, Ucraina
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Uzhgorod, Ucraina
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Budapest, Ungheria
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Nyiregyháza, Ungheria
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Szombathely, Ungheria
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Székesfehérvár, Ungheria
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Torokbalint, Ungheria
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Zalegerzeg-Pózva, Ungheria
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
- Immunohistochemical evidence of EGFR expression on tumor tissue
- Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area
Exclusion Criteria:
- Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
- Previous chemotherapy for NSCLC
- Documented or symptomatic brain metastasis
- Superior vena cava syndrome contra-indicating hydration
- Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Cetuximab plus chemotherapy
cetuximab + cisplatin + vinorelbine
|
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v.
infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v.
infusion on days 1 and 8 of each 3-week cycle.
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Comparatore attivo: Chemotherapy alone
cisplatin + vinorelbine alone
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cisplatin 80mg/m^2 i.v.
infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v.
infusion on days 1 and 8 of each 3-week cycle.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Survival Time (OS)
Lasso di tempo: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Time from randomization to death.
Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression-free Survival Time
Lasso di tempo: Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Best Overall Response Rate
Lasso di tempo: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
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Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Disease Control Rate
Lasso di tempo: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
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Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Lasso di tempo: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Mean global health status scores (EORTC QLQ-C30) against time for each treatment group.
Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation.
Higher scores indicate a better QoL.
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at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Lasso di tempo: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group.
Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation.
Higher scores indicate a higher level of functioning.
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at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
Lasso di tempo: Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.
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Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.
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Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.
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Safety - Number of Patients Experiencing Any Adverse Event
Lasso di tempo: time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Please refer to Adverse Events section for further details
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time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Robert Pirker, Professor, Universitätsklinik für Innere Medizin I, Wien
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.
- Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.
- Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.
- O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.
- Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2004
Completamento primario (Effettivo)
1 luglio 2007
Completamento dello studio (Effettivo)
1 maggio 2012
Date di iscrizione allo studio
Primo inviato
7 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
7 settembre 2005
Primo Inserito (Stima)
8 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
25 giugno 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 giugno 2014
Ultimo verificato
1 giugno 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Cisplatino
- Vinorelbina
- Cetuximab
Altri numeri di identificazione dello studio
- EMR 62202-046
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .